| Primary Device ID | 00607567201101 |
| NIH Device Record Key | 34cde81c-5451-426c-958e-88c5b2395608 |
| Commercial Distribution Discontinuation | 2018-07-20 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Sm Patient ECC Pack w/Quad iD |
| Version Model Number | BEQ-TOP 8102 |
| Catalog Number | 701049526 |
| Company DUNS | 001660786 |
| Company Name | DATASCOPE CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com | |
| Phone | 18886278383 |
| cpsurgery@maquet.com |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607567201101 [Primary] |
| DWE | Tubing, Pump, Cardiopulmonary Bypass |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00607567201101]
Ethylene Oxide
[00607567201101]
Ethylene Oxide
[00607567201101]
Ethylene Oxide
[00607567201101]
Ethylene Oxide
[00607567201101]
Ethylene Oxide
[00607567201101]
Ethylene Oxide
[00607567201101]
Ethylene Oxide
[00607567201101]
Ethylene Oxide
[00607567201101]
Ethylene Oxide
[00607567201101]
Ethylene Oxide
[00607567201101]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-12-02 |
| Device Publish Date | 2017-02-13 |
| 10607567113432 - CARDIOSAVE HYBRID, 3.1 EDITION | 2024-09-17 CARDIOSAVE HYBRID, 3.1 EDITION |
| 10607567113449 - CARDIOSAVE RESCUE, 3.1 EDITION | 2024-09-17 CARDIOSAVE RESCUE, 3.1 EDITION |
| 10607567114187 - CARDIOSAVE HYBRID - TYPE "N" PLUG | 2024-09-17 CARDIOSAVE HYBRID - TYPE "N" PLUG |
| 10607567107585 - YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT | 2024-08-20 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT |
| 10607567107592 - YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA) | 2024-08-20 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA) |
| 10607567107608 - YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT | 2024-08-20 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT |
| 10607567107639 - YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA) | 2024-08-20 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA) |
| 10607567111537 - Catheter Extender for Yamato Plus IABs - 10 Pack | 2024-08-20 Catheter Extender for Yamato Plus IABs - 10 Pack |